463 PHT Semi Solid Products

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463 PHTCompendia requirement for Semisolid

Nahla S Barakat, PhDDept. of Pharmaceutics

College of Pharmacy1430-2009
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IDEALPROPERTIESOFSEMI-SOLIDDOSAGEFORMS

Physical properties

a)Smooth texture

b)Elegant in appearance

c)Non dehydrating d)Non gritty

e)Non greasy and non staining

f)Non hygroscopic

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Storage properties

Stable under various real world storage conditions as per

ICH guidelines. Storage of semisolids should be at temperatures not

exceeding 25 unless otherwise authorized.

They should not be allowed to freeze and must be stored ina well-closed container or, if the preparation contains wateror other volatile ingredients, store in an air-tight container.

The containers are preferably collapsible metal tubes fromwhich the preparation may be readily extruded.

If the preparation is sterile, store in a sterile, airtight,

tamper-proof container.

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http://www.ich.org/http://www.ich.org/


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Microbial content Minimum fill

Packaging

Storage Labeling

Sterility

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Microbial content

These products should meet the acceptable standards for

microbial content Microbial limits are stated for each preparation in the USP

Ex. Betamethazone valerate oint. USP Must meet the

requirement of test for absence of Staph and Pseudo.

Aeruginisa These organisms have capacity to infect the skin

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To minimize both the type and the number of microorganisms

in unsterilized pharmaceutical product, there should be strict

adherence to environmental control and application of good

manufacturing practice

Dermatological product should be examined for P. aeruginosa

and S. aureus

Rectal, urethral, or vaginal product should be tested for yeast,

moulds because they are common offender at these sites

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Test raw material

Use of acceptable water

In process control

Final product testing

The USP stated that certain products should be routinely tested

for microorganism because the way they are used

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Procedure

10 gm or 10 ml of the products is tested after suitable dilution

and added to a specific media and incubate between 30-35 C

for 24-48 h

For purpose of confirming a doubtful result, a retest on 25 gm

specimen of the product may be conducted.

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The average net content of the 10 containers is not less than

the labeled amount, and the net content of any single container

is not less than 90% of the labeled amount where the labeled

amount is 60 g or 60 ml or less .

Or not less than 95% of the labeled amount where the content

is 60 g/or ml 150 g /or ml.

If this requirement is not met, determine the content of 20

additional containers.

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Leakage test

- Select 10 sealed tubes of the ointment

- Clean and dry the exterior surfaces

- Place the tubes with an absorbent sheet in oven at 60 C 3

for 8 hours

- If leakage is observed from one, but not more than one, of

the tubes, repeat the test with 20 additional tubes - The requirement is met if no leakage is observed from the

first 10 tubes, or if leakage is observed from not more than 1

of 30 tubes tested.

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Ointments and other semisolids are packed in :

Large-mouth jar

Metal or plastic tubes

Well closed containers to protect against contamination

Cool place to protect against product separation by heat

When requires light resistance or opaque container for light

sensitive drugs

In addition to the usual labeling, the USP directs that for

certain ointments and creams include the type of base used

either water soluble or water insoluble

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To ensure within lot-to-lot uniformity;

Viscosity

In vitro release

Texture: feel upon application (grittiness) Particle size distribution

pH, odour, colour

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Design of product quality: product design concepts together

with quality assurance concepts must be developed with

ophthalmic sensitivity as a major consideration

General considerations

Raw materials: The selection of specific raw materials should

include specifications which assure batch-to-batchreproducibility of product quality. Particle size is necessary

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Particulates: The USP definition of an ophthalmic product

include the phrase: free from foreign particles Solution clarity is a requirement (by filtration)

It is equally important to fill into particle-free containers

Glass or plastic containers are normally washed, rinsed with

purified water, finally rinsed with filtered, particulate-freepurified water, then dried and sterilized

The filling operation is carried out in an atmosphere controlled

by laminar flow air control

The standard of Class 100 clean room should apply to themanufacture of ophthalmic products

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Formulation aspects

The formulation of ophthalmic solution requires

consideration of : Drug solubility

Buffer , pH

Tonicity

Clarity Viscosity Antimicrobial preservation

Safety sterility

Stability

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Metal Particle in ophthalmic ointments

Extrude as completely as practicable, the content of 10 tubesindividually into separate clear flat-bottom, 60 mm Petri

dish.

Cover the dishes and heat at 85 C for 2 h, to ensure that a

fully state is obtained.

Allow sample to cool to room temp. and to solidify

Remove the cover and invert the Petri dish on the stage of a

microscope equipped with eye-piece micrometer disk, direct

an illuminator above the ointment at 45 angle.

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Examine the entire bottom of the Petri dish for metal

particles.

Count the number of metal particles that are 50 m or larger.

The requirement are met if the total number of such particles

in all 10 tubes does not exceed 50, and if not more than 1

tube is found to contain more than 8 such particles. Repeat the test on 20 additional tubes,

if the total number of metal particles (50 m or larger) does

not exceed 150 in all 30 tubes tested, and if not more than 3

of the tubes contain more than 8 such particles each.

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Ophthalmic products are contained in low-densitypolyethylene dropper bottles, glass bottles with dropper, or

ointment tubes with an extended tip

Polyethylene is not well suited as a container for easily

oxidized substances

It can not be heat sterilized

Ethylene oxide is used as a sterilant

Adequate control of packaging materials is essential to product

quality

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463 PHT Semi Solid Products

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